SPYRAL DYSTAL Renal Denervation Global Clinical Study

NCT04311086 | Completed Results DMC FDA Device

• 1 other identifier: SPYRAL DYSTAL
• Study Type: interventional
• Target: 128
• Locations: 4 countries
• Sites: 8

Brief Summary

The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach used in the SPYRAL HTN-OFF MED clinical study.

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Keywords

Uncontrolled hypertension; Renal denervation

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

  From Baseline (SV2) to 12 months post-procedure

Secondary Outcomes (15)

• Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

  From Baseline (SV2) to 3 months post-procedure

• Change in Office Systolic Blood Pressure (SBP)

  From Baseline (SV2) to 3 months post-procedure

• Change in Office Systolic Blood Pressure (SBP)

  From Baseline (SV2) to 12 months post-procedure

• Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

  From Baseline (SV2) to 3 months post-procedure

• Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

  From Baseline (SV2) to 12 months post-procedure

Other Outcomes (7)

• Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24- Ambulatory Blood Pressure Monitor (ABPM) at 3 Months Post-procedure From Baseline

  3 months post-procedure

• Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 3 Months Post-procedure From Baseline

  3 Months post-procedure

• Office Systolic Blood Pressure (SBP) Reduction

  From Baseline (SV2) to 3 months post-procedure

Study Arms (1)

Renal Denervation

EXPERIMENTAL

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Device: Renal Denervation (Symplicity Spyral™)

Interventions

Renal Denervation (Symplicity Spyral™) DEVICE

Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Also known as: Renal Angiography, Renal Denervation

Renal Denervation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
• Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and \< 170 mmHg.
• Individual is willing to discontinue current antihypertensive medications

You may not qualify if:

• Individual has estimated glomerular filtration rate (eGFR) of \<45.
• Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
• Individual has one or more episodes of orthostatic hypotension.
• Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
• Individual has primary pulmonary hypertension.
• Individual is pregnant, nursing or planning to become pregnant.
• Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
• Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
• Individual works night shifts.

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (8)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

Universitaetsklinikum Erlangen

Erlangen, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Hippokration General Hospital of Athens

Athens, Greece

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sara Dinkins SPYRAL DYSTAL Global Study Manager
• Organization: Medtronic

rs.spyraldystal@medtronic.com

303-840-4034

Study Officials

• David P Lee, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Andrew Sharp, MD

  University Hospital of Wales

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 17, 2020
• Study Start: June 12, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Locations

US (3); DE (3); GR (1); GB (1)